Kornimate/medical-research-clean huggingface dataset:
long-term follow-up study of glpg0634 in active rheumatoid arthritis participants

Conditions: Rheumatoid Arthritis

Summary: the primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly glpg0634) for the treatment of rheumatoid arthritis. participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, glpg0634-cl-203 (darwin1) (nct01888874) or glpg0634-cl-204 (darwin2) (nct01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. during the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.


Eligibility criteria:
key inclusion criteria: * participants who completed one of the qualifying core studies glpg0634-cl-203 or glpg0634-cl-204 and may benefit from filgotinib long-term treatment according to the investigator's judgment * females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib key exclusion criteria: * participants who prematurely withdrew from one of the 2 core studies (glpg0634-cl-203 or glpg0634-cl-204), for any reason * persistent abnormal lab values during one of the 2 core studies (glpg0634-cl-203 or glpg0634-cl-204), according to the investigator's judgment * diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary sjogren's syndrome * any condition or circumstances which, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: methotrexate insufficient responders
vibration stimuli in stroke patients with contraversive pusher syndrome

Conditions: Stroke

Summary: the purpose of this study is to investigate the effects of vibration stimuli to contra lateral neck muscles on contraversive pusher syndrome, function and neglect in stroke patients.

12 post-stroke subjects will be recruited from neurological rehabilitation department at loewenstein rehabilitation hospital, raanana, israel. the patients will be randomly assigned to one of two groups: 1) experimental group. 2) control group. the 2 weeks intervention (10 sessions) in each group will include vibration stimuli (frequency of 1 hz and amplitude of 20 mm) for 20 minutes and structured standard physiotherapy for 45 minutes. the vibration stimuli in the experimental group will be done to the contralesional neck muscles, whereas the vibration stimuli in the control group will be done in the contralesional hand. different assessments will be done before the intervention, after the first day of intervention, after two weeks of intervention and one months post-intervention. the tests will include: clinical scale for contraversive pushing, lateropulsion scale, subjective straight ahead, postural assesment scale for stroke patients, anterior and lateral functional reach test, posturography, behavioral inattention test, mesulam cancellation test, line bisection test, dynamic starry night and sensation. differences between groups will be calculated using t-tests or mann-whitney, depending on distribution of normality with corrections for multiple comparisons. smallest real difference (srd) will be calculated for detecting the minimal detectable change.

Eligibility criteria:
inclusion criteria: * first stroke * age 25-75 years * able to understand research instructions * stable clinical/metabolic state. * having contraversive pushing syndrome, based on clinical scale for contraversive pushing. exclusion criteria: * having previous neurological and orthopedic disability. * having pacemakers.

Keywords: vibration stimuli contraversive pusher syndrome
early outpatient hysteroscopy can prevent intrauterine adhesion after induced abortion

Conditions: Hysteroscopy; Intrauterine Adhesion

Summary: background: intrauterine adhesions are a difficult clinical problem for reproductive infertility. the most common cause is uterine cavity surgery and post-abortion (including abortion and spontaneous abortion). after the abortion, the uterine cavity adhesion, when is the key point, the literature is not much ink, early literature has mentioned that after the abortion, the uterus scraping action is scraped in four days and the uterine adhesion will be smaller than one to four weeks. much more, it seems that the sooner the uterine adhesion factor is excluded, the more it can reduce uterine adhesion, but the uterine curettage itself is a risk factor for uterine adhesion. this early practice, the current clinical application, is not used, instead, it is a hysteroscopy. our past clinical observations, as soon as possible after the abortion, outpatient hysteroscopy, can find the tissue factors that may cause adhesion in the uterine cavity as soon as possible, and immediately remove it with an outpatient hysteroscope. objective: to verify the early outpatient hysteroscopy and reduce the occurrence of intrauterine adhesion after abortion. expected benefits to patients: abortion is likely to cause intrauterine adhesions, which may further cause the incidence of reproductive infertility, should be involved before the formation of permanent injury, reduce the adhesion of the uterine cavity. outpatient hysteroscopy is a simple and easy-to-use examination procedure that is painless and does not require anesthesia. although it is invasive but has few complications, it is expected to reduce the occurrence of intrauterine adhesion after abortion.


Eligibility criteria:
inclusion criteria: * female age 20 to 45 years-old * undergo induced abortion * desire future fertility * agree with the trial and sign the consent form exclusion criteria: * previous intrauterine surgery * previous intrauterine adhesion * previous having over(and/or equal to) 3 times of induced abortion * infection condition

Keywords: induced abortion uterine adhesions reproductive infertility hysteroscopy
interleukin-1 blockade with canakinumab to improve exercise capacity in patients with chronic systolic heart failure and elevated high sensitivity c-reactive protein (hs-crp)

Conditions: Prior Acute Myocardial Infarction; Evidence of Systemic Inflammation (C Reactive Protein Plasma >2 mg/l); Reduced Left Ventricle Ejection Fraction (<50%); Symptoms of Heart Failure (NYHA Class II-III)

Summary: the proposed study is a sub-study of the cantos trial (a randomized, double-blind, placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated high sensitivity c-reaction protein (hscrp) \[cacz885m2301\]). the study proposes to perform serial cardiopulmonary exercise tests (cpx) to prospectively measure changes in aerobic exercise capacity in patients with prior myocardial infarction (mi), elevated c reactive protein plasma levels, and symptomatic heart failure with reduced systolic function, who are enrolled in the main cantos trial and are randomly assigned to canakinumab (3 different doses) or placebo. the subjects enrolled in this substudy will undergo repeated cpx and echocardiograms over the first 12 months of the cantos trial. the subjects will received the experimental treatment as randomized in the main cantos trial and they will not receive any additional experimental treatment as part of the sub-study. this study is a an investigator-initiated (dr. abbate) single-center (virginia commonwealth university) sub-study of the cantos trial, supported by novartis pharmaceuticals.

patients enrolled in the cantos trial (with prior acute myocardial infarction \[\>30 days\] and elevated c reactive protein levels \[crp\>2mg/l\]) who also have reduced left ventricular ejection fraction (lvef\<50%) and are symptomatic for heart failure (new york heart association symptoms class ii-iii) will be offered to take part in this sub-study at the virginia commonwealth university site. as part of the sub-study, patients will undergo a cardiopulmonary exercise test (cpx) at baseline prior to initiation of treatment, then repeated at 3 and 12 months, and a transthoracic echocardiogram at baseline and at 12 months.

Eligibility criteria:
inclusion criteria: * all criteria listed in the cantos trial (cacz885m2301) * left ventricular ejection fraction \<50% * symptoms of heart failure (nyha class ii-iii) exclusion criteria: * all criteria listed in the cantos trial (cacz885m2301) * inability to complete a treadmill exercise test * conditions preventing interpretation of the cardiopulmonary test (arrhythmias, ischemia, hypertension, pulmonary disease)
the professional peer resilience initiative

Conditions: Stress; Stress Disorder; Stress, Psychological; Trauma, Psychological; Anxiety; Anxiety State; Post Traumatic Stress Disorder; Secondary Traumatic Stress; Professional Quality of Life; Stress Related Disorder; Stress Reaction; Stress Risk; Mental Resilience; Emotional Resilience

Summary: the professional peer resilience initiative (ppri) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the university of minnesota (umn) healthcare workforce during the coronavirus disease 2019 (covid-19) pandemic. the study is being conducted concurrently with a umn peer support program called the minnrap program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the minnrap program and throughout their participation in the program.


Eligibility criteria:
inclusion criteria: * healthcare workers (hcws) and mental health consultants (mhcs) in umn medical school departments exclusion criteria: * none

Keywords: resilience covid-19 coronavirus disease 2019 coronavirus healthcare workers frontline traumatic stress
fondaparinux as an anticoagulant in haemofiltration in patients with acute kidney failure.

Conditions: Renal Failure

Summary: the purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.

the study hypothesis is that when used as an anticoagulant in haemofiltration, fondaparinux prolongs the filter life when compared to enoxaparin. fondaparinux is the first compound of a new class of synthetic oligosaccharides with antithrombotic effects. it represents the active portion of the natural heparin molecule. the null hypothesis is that there is no difference in filter life when using fondaparinux or enoxaparin as anticoagulation for haemofiltration.

Eligibility criteria:
inclusion criteria: 1. adult patients (18 years or over) admitted to the icu and expected to stay for more than 48 hours. 2. patients who require continuous renal replacement therapy. 3. patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. . - exclusion criteria: 1. patients aged less than 18 years of age. 2. patients who are pregnant 3. patients with a contraindication to anticoagulation for pre existing bleeding diathesis 4. patients or next of kin who do not consent to study inclusion. -
effect of informing family members of patients during surgery

Conditions: Anxiety

Summary: psychological and physiological issues encountered by family members due to the intraoperative process are factors that complicate the support and care systems of the patient. it is stated that family members of patients undergoing surgery, especially those who do not have sufficient information about the surgical process, experience stress, anxiety, and concern. the need for nursing interventions aimed at providing information about the surgical process, reducing the anxiety levels of family members during the surgery, and supporting them is emphasized. in this context, the study aims to evaluate the effect of periodically informing family members of patients undergoing abdominal cancer surgery via phone during the surgery on their anxiety levels.

once the patient scheduled for surgery is taken to the operating room, communication between the family members and the surgical team, as well as the patient, is cut off. family members who do not have any information about the progress of the surgery experience anxiety during the waiting period. high levels of anxiety can limit the family members' ability to understand and process information, affecting their ability to cope with the situation. the high anxiety experienced by family members during the surgery can reflect onto the patient postoperatively, potentially negatively impacting the patient's adaptation, recovery process, and family relations. it is known that family members of patients undergoing cancer surgery experience a higher level of anxiety. the anxiety emerging during this process leads to various physiological and psychological negative consequences for the family members. it is known that informing family members by nurses during surgery helps reduce their anxiety. in this direction, the primary aim of the study is to determine the effect of periodically informing family members of patients undergoing abdominal cancer surgery via phone during the surgery on their anxiety levels. additionally, the study will evaluate the satisfaction levels of the participants.

Eligibility criteria:
inclusion criteria: * being a first-degree relative who has given consent, * being able to understand and speak turkish, * being literate, * willing to participate in the study, * using a phone, * being present in the hospital before, during, and after the surgery. exclusion criteria: * having a hearing or speech impairment, * having a psychiatric disorder or using psychiatric medication. endpoint criteria: * inability to reach the participant when called during the surgery, * the patient's death during the surgery.

Keywords: anxiety informing relatives of the patient phone call satisfaction
oral vt-464 in patients with castration-resistant prostate cancer previously treated with enzalutamide, androgen receptor positive triple-negative breast cancer patients, and men with er positive breast cancer

Conditions: Prostate Cancer

Summary: the goal of this clinical study is to determine the safety and efficacy of vt-464, a lyase-selective inhibitor of cyp17, in patients with castration-resistant prostate cancer (crpc) who have been previously treated with enzalutamide, androgen receptor positive triple-negative breast cancer patients, and men with er positive breast cancer.

this is a phase 2 open-label study of vt-464 in patients with progressive, metastatic castration-resistant prostate cancer (mcrpc) who have been previously treated with enzalutamide, female patients with triple negative, ar positive breast cancer and men with er positive breast cancer. the study consists of five cohorts: patients in cohort 1 must have never received prior chemotherapy. patients in cohort 2 must have received at least one (and not more) prior course of chemotherapy for crpc. women with tnbc will be stratified into two cohorts ar 1 to 9% (cohort 3) and ar \> 10% (cohort 4). cohort 5 will consist of men who have been diagnosed with er+ breast cancer and have failed at least one prior endocrine therapy.

Eligibility criteria:
key eligibility criteria: * patients must have documented histological or cytological evidence of adenocarcinoma of the prostate. * must have progressive, metastatic castration-resistant prostate cancer (mcrpc). there must be radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising psa levels on successive measurements) despite adequate androgen-deprivation therapy, which is defined as having undergone bilateral surgical castration or continued treatment on gnrh agonists or antagonists. * all patients in this trial must have been treated with enzalutamide. * patients in cohort 1 will not be allowed to have received prior chemotherapy; patients in cohort 2 must have received one (and not more) prior course of chemotherapy for mcrpc. * progression must be evidenced and documented by any of the following parameters: * psa progression defined by a minimum of two rising psa levels with an interval of ≥ 1 week between each determination * appearance of one or more new lesions on bone scan * progressive measurable disease by recist 1.1

Keywords: mcrpc metastatic castration-resistant prostate cancer
ischemic compression on post-needling soreness

Conditions: Neck Pain

Summary: myofascial trigger points (mtrps) are identified through physical examination as hypersensitive spots within taut bands of skeletal muscle, painful on compression, triggering characteristic referred pain and generating motor dysfunction as well as autonomic phenomena. different dry needling procedures have been described in the treatment of mtrps. needling therapies which consist in partially inserting and withdrawing the needle from the trigger point site in order to elicit local twitch responses are associated with higher effectiveness in releasing mtrps. deep dry needling has obtained a grade a recommendation compared to sham, for immediate reduction of pain in patients with upper-quadrant myofascial pain syndrome. nevertheless, trigger point dry needling are frequently associated to a post-needling soreness. the application of ischemic compression (ic) after trigger point injection in the upper trapezius muscle has shown higher reduction of pain and disability in myofascial pain patients, compared with trigger point injection alone. to the authors' knowledge, no previous studies have evaluated the effectiveness of ic or any manual therapy methods for the treatment of post-needling soreness. the aims of this study were: (a) to evaluate the effectiveness of ic on reducing post-needling soreness after dry needling of one latent mtrp in the upper trapezius muscle, and (b) to investigate the effect dry needling combined with ic, compared to dry needling alone and dry needling combined with placebo ic will have on cervical range of motion (c) to determine whether psychological factors are predictive of postneedling pain and (d) to analyze if the relationships between psychological variables and postneedling pain varied as a function of postneedling soreness treatment


Eligibility criteria:
inclusion criteria: * subjects were included if they presented at least one latent mtrp in the upper trapezius muscle exclusion criteria: * presence of coagulation disorders * neck or facial pain * previous application of a dry needling technique * mtrp therapy in head or neck within the previous 3 months * fibromyalgia * an insurmountable fear of needles as a reason of refusing the treatment * history of surgery in the head or neck area

Keywords: ischemic compression myofascial trigger points post-needling soreness
safety of primaquine + artemether-lumefantrine in g6pd deficient males with an asymptomatic malaria infection (safeprim)

Conditions: Malaria

Summary: the purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in g6pd deficient males with an asymptomatic p. falciparum malaria infection.


Eligibility criteria:
inclusion criteria: 1. male gender 2. age ≥18 years and ≤45 years 3. bmi ≥16 4. p. falciparum parasitaemia at any density 5. g6pd deficiency by beutler fluorescent spot test for intervention groups and control group receiving al only (n=50) 6. g6pd normal activity by beutler fluorescent spot test for control groups (n=20) 7. informed consent by participant exclusion criteria: 1. enrolled in another clinical trial 2. fever \>37.5°c (tympanic) or history of fever in the last 24 hours 3. evidence of severe illness / danger signs or active infection other than malaria 4. known allergy to study medications 5. hb \<11 g/dl 6. antimalarials taken within the last 2 weeks 7. pq taken within the last 4 weeks and blood transfusion within the last 90 days 8. non-falciparum malaria co-infection 9. current use of tuberculosis or anti-retroviral medication, sulphonamides, dapsone, nitrofurantoin, , nalidixic acid, ciprofloxacin, , methylene blue, toluidine blue phenazopyridine and co-trimoxazole. 10. history of severe chronic illness

Keywords: g6pd deficiency safety transmission
exosomes implication in pd1-pd-l1 activation in osas

Conditions: Sleep Apnea Syndromes, Obstructive; Cancer

Summary: an increased occurrence of cancer associated mortality has been described in patients with obstructive sleep apnea syndrome (osas). this association might be partially explained by an impaired cellular immune response that has been described in osas. is has been suggested that osas impact immune cells by upregulation of the pd-1/pd-l1 pathway. exosomes are small membrane vesicles released by numerous cells in the bloodstream. exosomes have been shown to be implicated in cancer cells proliferation via a pd-1/pd-l1 pathway activation. this study will evaluate exosomal pd-1/pd-l1 expression in patients with osas as compared to controls and will further investigate their impact on immune cells function and proliferation capacities.


Eligibility criteria:
inclusion criteria: * patients requiring a sleep recording for suspected osas exclusion criteria: * préviously treated osas * cancer past history * pregnant women * cognitif impairment